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The Institute for Agriculture and Trade Policy[i] (IATP) appreciates this opportunity to comment on “reasonable alternatives and possible issues to be evaluated in the environmental impact statement” (Federal Register Vol. 81, No. 24, February 5, 2016, at 6225). IATP understands that the programmatic EIS resulting from the “Notice of Intent to Prepare an Environmental Impact Statement” (Notice) will be consistent with the guidance of the “Coordinated Framework for the Regulation of Biotechnology,” (Coordinated Framework) once it has been revised.[ii] IATP has submitted comments regarding that revision,x` and the following comment also reflects some of our views on the Coordinated Framework.[iii] Furthermore, APHIS is reconsidering amendments to its biotechnology regulations concurrent with developing the agency’s programmatic EIS (FR 6226). As a result, IATP will comment on the Notice while taking into consideration the broader policy context of the Coordinated Framework and the statutory basis for the biotechnology regulations.

As indicated throughout the Notice, changes to APHIS biotechnology regulations will apply to a host of new gene modification techniques that are partly illustrated in the Notice’s proposed indicative definition of “biotechnology” (FR 6227).  IATP agrees with the authors of a 2002 National Research Council report: “before making specific, precedent-setting decisions, APHIS should solicit broad external scientific review well beyond the use of Federal Register notices.”[iv] The decisions that APHIS will make about a programmatic EIS for current and future genetically engineered (GE) crops certainly qualify as precedent-setting. IATP hopes that APHIS will follow this and other recommendations of the National Research Council report, e.g. regarding the need for APHIS post-market monitoring of GE crops.

Introduction: historical context of the Notice and the APHIS proposed “Take no action” option

The four alternatives that APHIS presents for the design of a programmatic EIS, under the authority of the National Environmental Policy Act (NEPA) and the policy guidance of the yet to be revised 1992 Coordinated Framework, are presented in a remarkable historical context: as of 2012, “a full EIS was never completed for any of [more than 80] GE crops on the market; that is, until a [U.S. Supreme] court ordered one for RR [Roundup Ready®] alfalfa.”[v] (According to the General Accountability Office, “As of October 2015, USDA had deregulated 118 GE plants.”[vi]) Instead, APHIS has determined that the deregulated GE crops do not pose a significant environmental risk under the terms of NEPA, and therefore, has filed much less comprehensive Environmental Assessments (EAs) for deregulated GE crops. APHIS EAs delineate the agency’s authority over GE crops to distinguish it from that of the Food and Drug Administration and the Environmental Protection Agency. APHIS reviews applicant supplied data and information to develop the EAs for the non-regulated crops.

In the case of a successful 2004 application by Monsanto for deregulation of two of its GE alfalfa “events,” the EA stated that “glyphosate would provide a different herbicide mode of action in the growers’ crop rotation, which is important in preventing the development of herbicide resistant weeds. Glyphosate is applied like any other post-emergent herbicide used in any other crop. Glyphosate tolerant alfalfa may alter current alfalfa cultivation practices by allowing for reduced herbicide use in comparison to current practices in order to achieve the same crop yield.”[vii] This and other sections of the EA, which depend on the applicant’s optimistic assumptions about how the deregulated GE crop would perform in the field, were spectacularly erroneous. (Weed resistance and pesticide volume increases resulting from deregulated GE crop planting had already been reported when Monsanto applied to deregulate RoundUp Ready® alfalfa.[viii]

Unfortunately, herbicide resistant acreage and glyphosate use have increased dramatically since 1995, not only in the United States and not only for GE crops, although herbicide resistance to GE crops accounts for the majority of resistance acreage.[ix] Just on the basis of the environmental and economic consequences of herbicide resistance to GE crops designed for use with proprietary herbicides alone, the first alternative APHIS proposes for the EIS, “Take no action” to change existing regulations, is clearly unacceptable. 

In view of the growing economic and environmental cost of GE crop herbicide resistance, APHIS should regulate GE crops designed to be used with proprietary herbicides as cropping systems and conduct an EIS of such cropping systems to include the potential and historical economic, environmental and public health impacts of the GE crop herbicides. The definition of “noxious weed” in the Plant Protection Act of 2000 (PPA, cited in FR 6226) provides ample authority for APHIS to regulate the GE crop designed to be used with a proprietary pesticide as a cropping system and to conduct an EIS of that cropping system: “The term ‘‘noxious weed’’ means any plant or plant product that can directly or indirectly injure or cause damage to crops (including nursery stock or plant products), livestock, poultry, or other interests of agriculture, irrigation, navigation, the natural resources of the United States, the public health, or the environment.” (Section 403, paragraph 10)[x] The quantifiable damage of the herbicide resistant weeds to the GE crops and to neighboring conventional and organic crops certainly is an indirect economic and environmental injury resulting from the GE cropping system. Designing the programmatic EIS to include indirect injury from the GE cropping systems, per statute, will help implement the adequate regulation of current and future GE crops designed for use with proprietary herbicides.

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[i] The Institute for Agriculture and Trade Policy (IATP) is a nonprofit, 501(c)(3) nongovernmental organization, headquartered in Minneapolis, Minn., with an office in Washington, D.C. Our mission states, “The Institute for Agriculture and Trade Policy works locally and globally at the intersection of policy and practice to ensure fair and sustainable food, farm and trade systems.”



[iv] Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation, National Research Council, 2002, 10.

[v] Kristina Hubbard and Neva Hassanein, “Confronting coexistence in the United States: organic agriculture, genetic engineering, and the case of Roundup Ready alfalfa,” Agri. Hum Values (2013) 30:325-335. DOI: 10.1007/s10460-012-9394-6. See “Monsanto et al. v. Geertson Seed Farms, U.S. Supreme Court, October Term, 2009. 

[vi] “Genetically Engineered Crops: USDA Needs to Enhance Oversight and Better Understand Unintended Mixing with Other Crops,” General Accountability Office, March 2016, GAO 16-241, 4-5.

[vii] USDA/APHIS Environmental Assessment: Monsanto Company and Forage Genetics International Petition 04-110-01p for Determination of Non-regulated Status for Roundup Ready® Alfalfa Events J101 and J163, October 2004, 12.

[viii] E.g. Michael DK Owen and Ian Zelaya, “Herbicide Resistant Crops and Weed Resistance to Herbicides,” Pest Manag Sci 61:301–311 (2005) DOI: 10.1002/ps.1015

[ix] Ian Heap, “International Survey of Herbicide-Resistant Weeds,” Weed Science Society of America, February 7, 2016.  and Charles Benbrook, “Impact of genetically engineered crops on pesticide use in the U.S.—the first sixteen years,” Environmental Science Europe, September 28, 2012.


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